Quality Planning and Assurance

5 Proactive Approaches Failure Modes and Effects Analysis and Control Plan

5.1 Understanding Failure Modes and Effects Analysis

5.1.1  Principle of Failure Modes and Effects Analysis

Process of Failure Modes and Effects Analysis

Any product or service can have various quality problems, such as defects, malfunctions, and delays, when customers use a product or take a service. Minimizing and preventing quality problems is a major task of quality planning in development.

Failure modes and effects analysis (FMEA) is a proactive approach to identify potential failures, assess their possible impacts, and recommend countermeasures in advance. The aims of doing FMEA are:

• To identify potential failure modes, and evaluate their possible impacts.
• To propose preventive actions, and prioritize these to mitigate higher risks of potential failures and reduce their impacts.
• To follow up on implementation plans to ensure improved quality of a product or service.

The FMEA approach can apply to a system, such as a product, service, process, or other business function. FMEAs are normally conducted for new and high-risk subsystems and main functions of a large or complex system. A specific FMEA may be dedicated to a subsystem, such as a design FMEA, service FMEA, or process FMEA. For a new product, both a design FMEA and process FMEA are normally required.

Design FMEA is very similar to the DRBFM (design review based on failure mode) process discussed in Chapter 4, in terms of principle, process, ...